Assessment of Volume Status by Bedside Ultrasound in Children With Acute Gastroenteritis

Sponsor
Derince Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03021109
Collaborator
(none)
190
1
1
10
19

Study Details

Study Description

Brief Summary

The purpose of the study is assessment of volume status by bedside ultrasound in children with acute gastroenteritis

Condition or Disease Intervention/Treatment Phase
  • Device: Measurement of inferior vena cava diameters with ultrasound
N/A

Detailed Description

The research will be conducted of emergency medicine department in the Derince Training and Research Hospital. Patients referred to acute gastroenteritis will be included to the study. After initial evaluation, the clinician will inform the principal investigator about the patient. The principal investigator will record the patient's demographic data, contact information, vital signs, history, physical examination findings, and weight. Than expirium and inspirium diameters of vena cava inferior will be measured with the bedside ultrasound and caval index will be calculated. An investigator who have had an ultrasound certification by Emergency Medicine Association of Turkey for six years will make the measurements. After 1 week the patient will called up for re-evaluation. Applicants' weights will be measured again with the same weighing machine. The differences between initial and after one week weight measurement will be accepted as the gold standard method for volume loss. The weight loss of the patient, the dehydration findings detected on physical examination and the caval index will be compared.

Data will be collected on predesigned data sheets, by an investigator and subsequently will be entered into a spreadsheet (Excel 2007; Microsoft, Redmond, WA). All recorded data will be checked by an another investigator to identify possible errors. Results will be submitted at least every two months.

Linear regression will be performed with dehydration as the dependent variable and the caval index as the independent variable.

Study Design

Study Type:
Interventional
Actual Enrollment :
190 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assessment of Volume Status by Measurement of Caval Index by Bedside Ultrasound in Children With Acute Gastroenteritis
Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Oct 1, 2017
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Inferior vena cava diameteres

Measurement of inferior vena cava diameters with ultrasound

Device: Measurement of inferior vena cava diameters with ultrasound
The patient is placed in the supine position. Curvilinear probe is used. Subxiphoid view is obtained. The IVC is visualized in the longitudinal plane as it enters the right atrium. The diameter of the IVC for calculation of the caval index is measured 2 cm from where it enters the right atrium

Outcome Measures

Primary Outcome Measures

  1. The correlation of caval index with the amount of fluid loss in pediatric patients with acute gastroenteritis [1 week]

Secondary Outcome Measures

  1. The correlation between physical examination findings and the amount of fluid loss in pediatric dehydration [1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients between 6 months and 18 years of age who presented to the Emergency Department with gastroenteritis
Exclusion Criteria:
  • congenital heart disease

  • chronic liver disease

  • chronic renal disease

  • patients or parents who doesn't want to enroll the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kocaeli Derince Training and Research Hospital Kocaeli Izmit Turkey 41900

Sponsors and Collaborators

  • Derince Training and Research Hospital

Investigators

  • Principal Investigator: Asım E. Özbek, Specialist, Kocaeli Derince Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
ASIM ENES ÖZBEK, Emergency medicine specialist, Derince Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT03021109
Other Study ID Numbers:
  • 2016/278
First Posted:
Jan 13, 2017
Last Update Posted:
Oct 17, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by ASIM ENES ÖZBEK, Emergency medicine specialist, Derince Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 17, 2017